The Food and Drug Administration (FDA) has approved Xyosted (testosterone enanthate; Antares) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

Xyosted is intended for at-home use via subcutaneous injection using the disposable QuickShot auto-injector. It is approved in 3 dosage strengths: 50mg, 75mg, and 100mg. “The subcutaneous dosing of Xyosted also removes transfer concerns commonly associated with gels and potentially reduces the need for in-office injection procedures that may require more frequent patient visits,” said Jed C. Kaminetsky, MD, a urologist at University Urology Associates, Medical Director of Manhattan Medical Research, clinical assistant professor of urology at New York University School of Medicine and principal investigator in the Xyosted pivotal studies. “Xyosted has been clinically shown to produce physiologically normal levels of testosterone with a narrow peak-to-trough ratio.”

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Xyosted carries a Boxed Warning regarding blood pressure increases that may potentially increase the risk for major adverse cardiovascular events. Before starting Xyosted therapy, baseline cardiovascular risk should be considered and blood pressure should be adequately controlled. In a 1-year clinical trial, 10% of Xyosted-treated patients were started on an antihypertensive agent or needed their blood pressure medication regimen changed.

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According to Antares, Xyosted is expected to be available by the end of 2018.

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This article originally appeared on MPR